Browse Device Recalls

22 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 22 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 22 FDA device recalls.

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DateProductReasonClassFirm
Mar 3, 2026 OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria ide... Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A l... Class II Oxoid Australia Pty Limited
Feb 1, 2021 Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910 Due to software defect, under certain assay parameters, false Vitamin D results may be reported. ... Class II Thermo Fisher Scientific
Apr 29, 2020 Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Cat... Product was not irradiated; therefore, they are not sterile and do not meet product specification. Class II Thermo Fisher Scientific (Monterrey)
Jul 18, 2019 Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, ... Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded... Class II Thermo Fisher Scientific (Monterrey)
Jul 18, 2019 Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen cont... Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded... Class II Thermo Fisher Scientific (Monterrey)
Apr 2, 2019 Thermo Scientific General Purpose Dynamic Bath Precision 5 & 10L Dual GP Bat... Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... Class II Thermo Fisher Scientific (Asheville) LLC
Apr 2, 2019 Thermo Scientific General Purpose Dynamic Bath Precision 28L GP Bath Model... Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... Class II Thermo Fisher Scientific (Asheville) LLC
Apr 2, 2019 Thermo Scientific General Purpose Dynamic Bath Precision 20L GP Bath Model... Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... Class II Thermo Fisher Scientific (Asheville) LLC
Apr 2, 2019 Thermo Scientific General Purpose Dynamic Bath Precision 2L-Shallow GP Bath ... Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... Class II Thermo Fisher Scientific (Asheville) LLC
Apr 2, 2019 Thermo Scientific General Purpose Dynamic Bath Precision 5L GP Bath Model N... Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... Class II Thermo Fisher Scientific (Asheville) LLC
Apr 2, 2019 Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath ... Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... Class II Thermo Fisher Scientific (Asheville) LLC
Apr 2, 2019 Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath ... Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... Class II Thermo Fisher Scientific (Asheville) LLC
Apr 2, 2019 Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 20L GP Bath ... Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... Class II Thermo Fisher Scientific (Asheville) LLC
Apr 2, 2019 Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model ... Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... Class II Thermo Fisher Scientific (Asheville) LLC
May 19, 2017 Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 0084527500... An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, li... Class II Fisher Diagnostics
May 19, 2017 Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determ... An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, li... Class II Fisher Diagnostics
Mar 17, 2016 enGen (TM) Laboratory Automation System configured with Thermo Scientific Rec... The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may l... Class II Ortho-Clinical Diagnostics
Dec 6, 2013 Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml... Reports that the product is not performing as expected. In house testing showed no staining on br... Class II Lab Vision Corporation
Oct 29, 2013 MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed)... Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet ... Class III Thermofisher Scientive
Oct 16, 2013 Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog... Microgenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot ... Class II Microgenics Corp
Nov 29, 2012 CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381,... Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in... Class II Thermo Fisher Scientific (Asheville) LLC
Aug 21, 2012 Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0... The firm is recalling the product due to some cartridges may contain individual discs that are no... Class II Remel Inc

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.